OncoMatch/Clinical Trials/NCT07098364
ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma
Is NCT07098364 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Vevoctadekin and Lisocabtagene Maraleucel for recurrent diffuse large b-cell lymphoma.
Treatment: Vevoctadekin · Lisocabtagene Maraleucel — This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology)
Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology
Prior therapy
Must have received: systemic therapy
at least 2 lines of systemic therapy
Cannot have received: CD19 CAR T-cell therapy
Prior treatment with any CD19 CAR T-cell therapy
Cannot have received: IL-1 or IL-18 agonist and/or biosimilar agents, or investigational agent
Prior treatment with any IL-1 or IL-18 agonist and/or biosimilar agents, or an investigational agent within 4 weeks or 5 half-lives, whichever is shorter, prior to start of lymphodepletion
Lab requirements
Blood counts
ANC >= 1000 cells/mm^3, platelets >= 50,000 cells/mm^3, and hemoglobin >= 8 g/dL, unless cytopenias are due to bone marrow involvement by lymphoma in the opinion of the PI
Kidney function
Calculated creatinine clearance (Cockcroft/Gault) > 30 mL/min/1.73 m^2
Liver function
ALT and AST <= 3 x ULN (or < 5 x ULN for subjects with lymphomatous infiltration of the liver); total bilirubin <= 2 (or < 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis)
Cardiac function
LVEF >= 40% as assessed by echocardiogram or MUGA
Adequate bone marrow function for lymphodepletion chemotherapy defined as: absolute neutrophil count (ANC) >= 1000 cells/mm^3, platelets >= 50,000 cells/mm^3, and hemoglobin >= 8 g/dL, unless the cytopenias are due to bone marrow involvement by lymphoma in the opinion of the principal investigator (PI); Calculated creatinine clearance (Cockcroft/Gault) > 30 mL/min/1.73 m^2; ALT and AST <= 3 x ULN (or < 5 x ULN for subjects with lymphomatous infiltration of the liver); total bilirubin <= 2 (or < 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis); LVEF >= 40% as assessed by echocardiogram or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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